The fraud, deception and damage Ranbaxy Laboratories Ltd. of India perpetrated around the world a decade ago in the form of shoddy and dangerous drug manufacturing practices, is legendary. It’s time to look back. Katherine Eban, author of “Bottle of Lies: The Inside Story of the Generics Drug Boom” has provided us the means.
How can the industry improve the quality of its products? The first tactic could be for the industry to increase the frequency of vendor inspections, using internal quality control programs to inspect suppliers to assure compliance with the necessary supply agreements and adherence to appropriate manufacturing practices, including GMPs.
You have just completed a full technical transfer to a CDMO for your commercial drug product. You selected this CDMO because it provides a wide range of support services and has a fully functional chemistry and microbiological laboratory, a manufacturing science and technology team, a production team that includes manufacturing and packaging, and a quality assurance team. This has been a two-year program and you are gearing up to launch the opening campaign.
Welcome to the sixth and final installment of this series on the proper selection and use of tools to help you improve Quality within your organization. This article ties together the previous five in this series with a treatise on the 7 Tools of Quality.
Methods for improving bioavailability are constantly evolving. Selecting the right approach is key to achieving a good formulation that reduces the frequency of dosing and improves patient compliance, as well as results in a low production cost.
There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.
The white paper includes a brief discussion around modern vaccine processes, followed by a case study showing the scale-up of upstream and downstream processes for the production of a cell based live attenuated influenza virus using single-use ReadyToProcess technology.
The use of monoclonal antibodies (MAbs) and MAb conjugates as biopharmaceuticals have increased over the last decade. As a result, more cost-effective, efficient, and flexible process purification solutions are of high priority for MAb manufacturers. Increasing product titers upstream can introduce challenges in downstream purification processes. With increased MAb titers, the cell culture supernatant might contain an elevated number of impurities (e.g., aggregates) that need to be separated from the target molecule.
Capsular polysaccharides (CPS) of encapsulated bacterial pathogens can give rise to an effective immune response in humans, and are commonly used in vaccine production. This whitepaper offers an overview of modern tools and technologies that can facilitate CPS-based vaccine production. An alternative purification approach based on chromatography, replacing many of the ethanol and phenol extraction steps of the traditional process, is also presented. Using the proposed purification platform, 28 different CPS of three different species could be processed to high purity and yield in a secure and environmentally friendly way.
To address the growing need for speed and efficiency in viral vector manufacturing, GE developed a process for adenovirus manufacturing that not only meets regulatory requirements but is also scalable.
Critical quality attributes (CQA) are fundamental to regulatory compliance and in drug development and manufacturing. Find out how surface plasmon resonance has been applied for protein characterization of antibody effector function.
In this technical note, Henry’s Law is reviewed, and various types of dissolved oxygen sensors are described and the performances evaluated and summarized.
'Omic technologies and systems biology research provide a comprehensive view of the genetic, protein and biochemical nature of disease.
Product development for injectable drugs requires a rigorous strategy and process consisting of four steps: (1) characterization, (2) formulation and development, (3) assurance of sterility (4) lyophilization. The process can be lengthy, expensive and risky, so it’s important to outsource to an experienced partner who can address the challenge involved. This white paper provides a roadmap for understanding how injectables are developed and offers suggestions on how to find the right outsourcing partner to manage the process
Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.
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Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.
About OutsourcedPharma.com
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
As novel medicines become a larger part of the industry's portfolio, it is critical you secure a supply chain and manufacturing processes that produce drugs in a reliable, cost-effective way.
The RMAT designation gives the sponsor of a new drug access to increased meeting opportunities with FDA, in a manner comparable to those offered to sponsors of breakthrough-designated therapies. In fact the RMAT may be considered as analogous to the breakthrough designation for regenerative medicine drugs.
Unexplored and emerging markets are an attractive prospect for biopharma companies looking to expand. But when it comes to ensuring success, what’s the wisest way to invest?
What can you do when the identification method defined by the USP monograph does not provide clear guidance? The authors decided to improve the method with a Quality by Design (QbD) approach.
When an employee performs a wide range of manufacturing tasks, both in and beyond his or her comfort zone, there is less likelihood of burnout.
